Vice President, Clinical Development

Alkeus Pharmaceuticals•Cambridge, MA

About The Position

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S. Position Summary: We are seeking a people focused and accomplished leader to join our team as the Vice President, Clinical Development to lead and expand the company’s clinical programs in retinal diseases. This role is a key leadership position responsible for the strategic planning, execution, and oversight of all clinical development programs, ensuring alignment with regulatory standards and company goals. This individual plays a critical role in shaping the clinical strategy, ensuring scientific rigor, regulatory compliance, and the timely progression of our pipeline and interactions with health authorities, board, investors, analysts, patient advocacy groups, retina specialists, and other stakeholders. This individual also leads and mentors a team of clinical development professionals, collaborate cross-functionally, and represent the company externally with key opinion leaders, investigators, and regulatory bodies.

Requirements

Advance degree required; MD, MD/PhD, or equivalent a plus; specialty training or experience in Ophthalmology is preferred.
Subspecialty training or deep experience in retina preferred.
5+ years of clinical development experience in the biopharmaceutical industry, with an emphasis on Ophthalmology and retinal diseases preferred.
A proven success record of leading new medicines through all stages of clinical development to approval a plus.
Late-stage development experience with designing, setting up, reading out, closing and filling phase 3 trials is preferred.
Proven leadership in designing and executing successful global clinical programs, including experience with pivotal/registrational trials with experience in rare disease drug development preferred.
Experience with, or strong knowledge of orphan or rare disease drug development preferred or experience or knowledge of ophthalmology drug development a plus.
Successful history of regulatory interactions and submissions (e.g., IND, NDA/BLA, Fast Track, Breakthrough Therapy).
Must have excellent leadership and interpersonal skills; should have proven skills as an effective collaborator who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
The successful candidate will possess excellent communication and presentation skills demonstrating the ability to articulate the Company’s clinical and regulatory strategies and progress to a wide audience, including senior management, the Board of Directors, Company employees and external stakeholders.
Collaborative mindset with strong interpersonal skills to drive cross-functional success.
Experience in early- and late-stage development (Phase I–III), ideally in both small and large molecules, gene therapy, or biologics targeting retinal disease.
Previous experience coordinating with commercial and marketing teams to support efforts, including medical expertise and collaboration to strengthen a successful product launch.
Entrepreneurial spirit with a passion to build, learn and evolve with the team.
Highly organized and detail oriented with a passion to deliver quality results.
Excellent verbal and written communication skills, with experience translating complex concepts for various audiences.
Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
Ability to lead fast-paced projects with a keen sense of urgency to get the job done well.
Evidence of "hands-on" experience and expertise
Proven and successful track record as a people-first leader, a team-player and collaborator in small working environments
Highest levels of professionalism, confidence, personal values, and ethical standards

Nice To Haves

MD, MD/PhD, or equivalent a plus; specialty training or experience in Ophthalmology is preferred.
Subspecialty training or deep experience in retina preferred.
A proven success record of leading new medicines through all stages of clinical development to approval a plus.
Late-stage development experience with designing, setting up, reading out, closing and filling phase 3 trials is preferred.
Proven leadership in designing and executing successful global clinical programs, including experience with pivotal/registrational trials with experience in rare disease drug development preferred.
Experience with, or strong knowledge of orphan or rare disease drug development preferred or experience or knowledge of ophthalmology drug development a plus.

Responsibilities

Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company’s strategic and operational goals.
Lead assigned clinical development team members across multiple clinical programs.
Oversee the review, analysis and interpretation of clinical trial data and the reporting of clinical trial results, including preparation of abstracts, presentations, and manuscripts.
As a senior leader in R&D, contribute to corporate strategy, investor relations, and business development initiatives.
Lead interactions with KOLs, advisory boards, and external stakeholders to guide study designs and development plans.
Participate in cross-functional teams, as needed, for assigned trials, collaborating with other team members to achieve efficient, high-quality study execution.
Provide input on regulatory strategies, reviewing, and approving where necessary, regulatory documents for submission to multiple regulatory agencies for the various clinical programs.
Lead interactions with academic thought leaders, investigators, cooperative groups, pharmaceutical partners/sponsors, patient advocacy groups, and other clinical stakeholders, developing relationships in support of clinical programs. Furthermore, engage in scientific and medical exchanges and identify unmet medical needs and gaps.
Ensure appropriate management and oversight of clinical studies in partnership with clinical operations leadership. This includes, but is not limited to, the development of clinical study protocols; contribute to the selection and management of external partners such as CROs and other vendors; provide input on site selection for studies, study management, medical monitoring, clinical study reports, investigators brochures, regulatory briefing documents, and clinical sections of regulatory filings.
Support clinical study teams, monitoring the overall study integrity, and reviewing, interpretatiing, and communicating accumulated data pertaining to safety and efficacy of the molecule.
Present at scientific, medical, and regulatory meetings globally.
Manage assigned budget, ensuring efficient resource utilization and investment in the areas of highest impact
Deliver on other related projects as assigned.

Benefits

Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan

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